A Phase III Study of High-Dose Intensification Without Hematopoietic Progenitor Cells Support for Patients With High-Risk Primary Breast Carcinoma
作者:
Jonathan Yau,
Stanley Gertler,
John Hanson,
Shailendra Verma,
Laval Grimard,
Saleem Malik,
Ibrahim Aref,
Peter Cross,
Eva Tomiak,
David Stewart,
Deborah St. Cyr,
Susan Huan,
期刊:
American Journal of Clinical Oncology: Cancer Clinical Trials
(OVID Available online 2000)
卷期:
Volume 23,
issue 3
页码: 292-296
ISSN:0277-3732
年代: 2000
出版商: OVID
关键词: Adjuvant chemotherapy;Breast cancer;High-dose chemotherapy
数据来源: OVID
摘要:
Patients with more than nine ipsilateral lymph node involvement or inflammatory breast cancer have a 5-year survival rate of approximately 50%. We studied the efficacy of high-dose intensification, comparing it with the standard dose chemotherapy for patients with high-risk primary breast cancer. Patients with inflammatory breast cancer or more than nine ipsilateral lymph node involvement without evidence of distant metastasis were randomized to receive either standard dose 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) every 3 weeks for nine courses (control) or six courses of FAC followed by two courses of cyclophosphamide (5.25 g/m2), etoposide (1,500 mg/m2), and cisplatin (165 mg/m2) (HDCVP). The study was terminated in 1998 because of slow accrual of patients. Forty-six patients were entered in the study. At 4 years, the overall survival was 72.8% (SE 11.9%) and 61.7% (SE 12.4%), and disease-free survival were 45.5% (SE 12.3%) and 33.7% (SE 11.9%) for the control and HDCVP groups, respectively (p= 0.757 and 0.720). With the small number of patients in our study, a small overall survival benefit of high-dose intensification compared with the standard therapy cannot be excluded. However, any substantial benefit is unlikely.
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